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https://www.readbyqxmd.com/read/27922194/pharmacodynamic-response-profiles-of-anxiolytic-and-sedative-drugs
#1
Xia Chen, Freerk Broeyer, Marieke de Kam, Joke Baas, Adam Cohen, Joop van Gerven
INTRODUCTION: Centrally-acting acutely anxiolytic drugs, like benzodiazepines, barbiturates and gabapentinoids, affect various central nervous system (CNS) functions, which reflect not only their anxiolytic effects but also neuropsychological side-effects. To validate the pharmacodynamic biomarkers for GABA-ergic anxiolytics, this study determined the pharmacodynamics of two anxiolytics and a non-anxiolytic control and linked them to their anxiolytic and sedative effects, during an anxiety-challenge study day...
December 6, 2016: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/27922030/histamine-2-receptor-antagonist-cannot-prevent-recurrent-peptic-ulcers-in-patients-with-atherosclerotic-diseases-who-receive-platelet-adp-receptor-antagonist-monotherapy-a-randomized-controlled-double-blind-and-double-dummy-trial
#2
Ping-I Hsu, Deng-Chyang Wu, Feng-Woei Tsay, Jin-Shiung Cheng, Chun-Peng Liu, Kwok-Hung Lai, Wen-Chi Chen, Huay-Min Wang, Tzung-Jiun Tsai, Kuo-Wang Tsai, Sung-Shuo Kao
OBJECTIVES: Proton pump inhibitor can effectively prevent recurrent peptic ulcers among atherosclerotic patients receiving clopidogrel monotherapy. However, the interaction between proton pump inhibitors and clopidogrel has raised concerns over the safety of combined use of the two medicines in clinical practice. The aims of this randomized-controlled, double-blind and double-dummy trial were to investigate the efficacy of histamine-2 receptor antagonist (H2RA) in the prevention of recurrent peptic ulcer in patients undergoing thienopyridine monotherapy...
December 6, 2016: American Journal of Gastroenterology
https://www.readbyqxmd.com/read/27922028/a-randomized-double-blind-placebo-controlled-trial-to-examine-the-effectiveness-of-lubiprostone-on-constipation-symptoms-and-colon-transit-time-in-diabetic-patients
#3
Jennifer Christie, Sagar Shroff, Nikrad Shahnavaz, Latoya A Carter, Melanie S Harrison, Karan A Dietz-Lindo, John Hanfelt, Shanthi Srinivasan
OBJECTIVES: Constipation is the most common GI symptom in patients with diabetes mellitus (DM). Importantly, patients with constipation have lower health-related quality of life than those without constipation. Effective therapies for constipation are limited and there is a paucity of data evaluating the treatment of constipation in diabetics. METHODS: Diabetic patients with chronic idiopathic constipation (CIC) as defined by Rome III criteria were recruited from outpatient clinics at a tertiary-care center and a Veterans Administration Hospital...
December 6, 2016: American Journal of Gastroenterology
https://www.readbyqxmd.com/read/27920515/effect-of-elom-080-on-exacerbations-and-symptoms-in-copd-patients-with-a-chronic-bronchitis-phenotype-a-post-hoc-analysis-of-a-randomized-double-blind-placebo-controlled-clinical-trial
#4
Kai-Michael Beeh, Jutta Beier, Henning Candler, Thomas Wittig
BACKGROUND: Treating symptoms and preventing exacerbations are key components of chronic obstructive pulmonary disease (COPD) long-term management. Recently, a more tailored treatment approach has been proposed, in particular for two well-established clinical phenotypes, frequent exacerbators and chronic bronchitis-dominant COPD. ELOM-080 has demonstrated clinical efficacy in treating symptoms and preventing exacerbations in subjects with chronic bronchitis. However, little is known about the potential effects of ELOM-080 in COPD patients...
2016: International Journal of Chronic Obstructive Pulmonary Disease
https://www.readbyqxmd.com/read/27920497/efficacy-and-safety-of-two-fixed-dose-combinations-of-s-amlodipine-and-telmisartan-ckd-828-versus-s-amlodipine-monotherapy-in-patients-with-hypertension-inadequately-controlled-using-s-amlodipine-monotherapy-an-8-week-multicenter-randomized-double-blind-phase
#5
Sang-Hyun Ihm, Hui-Kyung Jeon, Tae-Joon Cha, Taek-Jong Hong, Sang-Hyun Kim, Nae-Hee Lee, Jung Han Yoon, Namsik Yoon, Kyung-Kuk Hwang, Sang-Ho Jo, Ho-Joong Youn
PURPOSE: To evaluate the blood pressure (BP) lowering efficacy and safety of CKD-828, a fixed-dose combination of S-amlodipine (the more active isomer of amlodipine besylate, which is calcium channel blocker) and telmisartan (long acting angiotensin receptor blocker), in patients with hypertension inadequately controlled with S-amlodipine monotherapy. PATIENTS AND METHODS: Eligible patients (N=187) who failed to respond after 4-week S-amlodipine 2.5 mg monotherapy (sitting diastolic blood pressure [sitDBP] ≥90 mmHg) to receive CKD-828 2...
2016: Drug Design, Development and Therapy
https://www.readbyqxmd.com/read/27920018/a-phase-ii-randomized-placebo-controlled-trial-of-oral-n-acetylcysteine-for-protection-of-melanocytic-nevi-against-uv-induced-oxidative-stress-in-vivo
#6
Pamela B Cassidy, Tong Liu, Scott R Florell, Matthew Honeggar, Sancy A Leachman, Kenneth M Boucher, Douglas Grossman
Oxidative stress plays a role in UV-induced melanoma, which may arise from melanocytic nevi. We investigated whether oral administration of the antioxidant N-acetylcysteine (NAC) could protect nevi from oxidative stress in vivo in the setting of acute UV exposure. The minimal erythemal dose (MED) was determined for 100 patients at increased risk for melanoma. Patients were randomized to receive a single dose (1,200 mg) of NAC or placebo, in double-blind fashion, and then one nevus was irradiated (1-2 MED) using a solar simulator...
December 5, 2016: Cancer Prevention Research
https://www.readbyqxmd.com/read/27919901/safety-and-pharmacokinetics-of-cd101-iv-a-novel-echinocandin-in-healthy-adults
#7
Taylor Sandison, Voon Ong, Jonathan Lee, Dirk Thye
CD101 IV is a novel echinocandin with distinctive pharmacokinetic properties that is being developed as a once-weekly treatment for candidemia and invasive candidiasis. CD101 has potent in vitro activity and in vivo efficacy against a broad range of Candida and Aspergillus species. The primary objective of two randomized, double-blind, placebo-controlled, dose-escalation studies in healthy adults was to determine the safety and tolerability of CD101 IV. Sequential cohorts of 8 subjects (n=6, active; n=2, placebo) were administered single (50, 100, 200, 400 mg) or multiple once-weekly (100 mg ×2, 200 mg ×2, 400 mg ×3) doses of CD101 IV infused over 1 hour...
December 5, 2016: Antimicrobial Agents and Chemotherapy
https://www.readbyqxmd.com/read/27919806/are-placebo-and-drug-specific-effects-additive-questioning-basic-assumptions-of-double-blinded-randomized-clinical-trials-and-presenting-novel-study-designs
#8
REVIEW
Tobias Kube, Winfried Rief
Double-blinded randomized clinical trials (RCTs) assume that pharmacological interventions have drug-specific and unspecific components. Traditional RCTs postulate an additivity of these two components. In this review, we provide evidence from both clinical trials and experimental studies that questions this 'additive model'. Given that the evaluation of drug treatments in RCTs is based on the assumption of additivity, its violation has far-reaching consequences. Therefore, we discuss an interactive model that, in contrast to the additive model, considers interactions between placebo and drug-specific effects...
December 2, 2016: Drug Discovery Today
https://www.readbyqxmd.com/read/27919481/effect-of-slow-release-fampridine-on-muscle-strength-rate-of-force-development-functional-capacity-and-cognitive-function-in-an-enriched-population-of-ms-patients-a-randomized-double-blind-placebo-controlled-study
#9
H B Jensen, J L Nielsen, M Ravnborg, U Dalgas, P Aagaard, E Stenager
DESIGN: This study was conducted as a randomized, double blind, placebo-controlled parallel group trial preceded by open label enrichment phase. OBJECTIVES: The objectives of this study were 1) to examine the effect of SR-Fampridine treatment on muscle strength in terms of maximal voluntary contraction (MVC) and rate of force development (RFD) of the lower extremities and 2) to replicate previously published data on the effect of slow release-Fampridine (SR-Fampridine) on the functional capacity of the lower limbs, the upper limb and cognitive function, in persons with multiple sclerosis (pwMS)...
November 2016: Multiple Sclerosis and related Disorders
https://www.readbyqxmd.com/read/27919362/the-effect-of-omega-3-carboxylic-acids-on-apolipoprotein-ciii-containing-lipoproteins-in-severe-hypertriglyceridemia
#10
Allyson M Morton, Jeremy D Furtado, Jane Lee, William Amerine, Michael H Davidson, Frank M Sacks
BACKGROUND: Lipoprotein subspecies containing apoCIII adversely affect cardiovascular disease (CVD) risk; for example, low density lipoprotein (LDL) with apoCIII is a stronger CVD predictor than LDL without apoCIII. The Epanova for Lowering Very High Triglycerides (EVOLVE) trial showed that Epanova (omega-3 carboxylic acids [OM3-CA]) significantly lowered TG and apoCIII but raised LDL-C. However, it is unknown what subspecies of LDL were affected by treatment. OBJECTIVE: To determine how lipoprotein subspecies are affected by omega-3 fatty acid treatment, we studied the effect of OM3-CA on apoCIII concentrations in high density lipoprotein (HDL), LDL, and very low density lipoprotein (VLDL) and on the concentrations of subspecies of HDL, LDL, and VLDL that contain or do not contain apoCIII...
November 2016: Journal of Clinical Lipidology
https://www.readbyqxmd.com/read/27919356/lipoprotein-a-cholesterol-levels-estimated-by-vertical-auto-profile-correlate-poorly-with-lp-a-mass-in-hyperlipidemic-subjects-implications-for-clinical-practice-interpretation-of-lp-a-mediated-risk
#11
Calvin Yeang, Paul C Clopton, Sotirios Tsimikas
BACKGROUND: Lipoprotein(a) [Lp(a)] is generally measured as total mass of the entire particle or as apolipoprotein(a) particle number. OBJECTIVE: The cholesterol content of Lp(a) [Lp(a)-C)] can be estimated by the vertical auto profile (VAP) method. We assessed whether this is an accurate surrogate measurement of Lp(a) mass. METHODS: VAP-Lp(a)-C and VAP-high density lipoprotein cholesterol (HDL-C) estimated by the VAP technique, Lp(a) mass, oxidized phospholipids on apolipoprotein B-100 (OxPL-apoB) that primarily reflect OxPL on Lp(a), and HDL-C measured by enzymatic methods were measured in 552 hypercholesterolemic patients at baseline and 24 weeks after therapy with niacin monotherapy (N = 118), ezetimibe/simvastatin monotherapy (n = 155), or ezetimibe/simvastatin (10/20 mg) + niacin (to 2 g) (N = 279) in a randomized, double-blind trial...
November 2016: Journal of Clinical Lipidology
https://www.readbyqxmd.com/read/27918780/effect-of-a-proposed-trastuzumab-biosimilar-compared-with-trastuzumab-on-overall-response-rate-in-patients-with-erbb2-her2-positive-metastatic-breast-cancer-a-randomized-clinical-trial
#12
Hope S Rugo, Abhijit Barve, Cornelius F Waller, Miguel Hernandez-Bronchud, Jay Herson, Jinyu Yuan, Rajiv Sharma, Mark Baczkowski, Mudgal Kothekar, Subramanian Loganathan, Alexey Manikhas, Igor Bondarenko, Guzel Mukhametshina, Gia Nemsadze, Joseph D Parra, Maria Luisa T Abesamis-Tiambeng, Kakhaber Baramidze, Charuwan Akewanlop, Ihor Vynnychenko, Virote Sriuranpong, Gopichand Mamillapalli, Sirshendu Ray, Eduardo P Yanez Ruiz, Eduardo Pennella
Importance: Treatment with the anti-ERBB2 humanized monoclonal antibody trastuzumab and chemotherapy significantly improves outcome in patients with ERBB2 (HER2)-positive metastatic breast cancer; a clinically effective biosimilar may help increase access to this therapy. Objective: To compare the overall response rate and assess the safety of a proposed trastuzumab biosimilar plus a taxane or trastuzumab plus a taxane in patients without prior treatment for ERBB2-positive metastatic breast cancer...
December 1, 2016: JAMA: the Journal of the American Medical Association
https://www.readbyqxmd.com/read/27918778/efficacy-of-oral-risperidone-haloperidol-or-placebo-for-symptoms-of-delirium-among-patients-in-palliative-care-a-randomized-clinical-trial
#13
Meera R Agar, Peter G Lawlor, Stephen Quinn, Brian Draper, Gideon A Caplan, Debra Rowett, Christine Sanderson, Janet Hardy, Brian Le, Simon Eckermann, Nicola McCaffrey, Linda Devilee, Belinda Fazekas, Mark Hill, David C Currow
Importance: Antipsychotics are widely used for distressing symptoms of delirium, but efficacy has not been established in placebo-controlled trials in palliative care. Objective: To determine efficacy of risperidone or haloperidol relative to placebo in relieving target symptoms of delirium associated with distress among patients receiving palliative care. Design, Setting, and Participants: A double-blind, parallel-arm, dose-titrated randomized clinical trial was conducted at 11 Australian inpatient hospice or hospital palliative care services between August 13, 2008, and April 2, 2014, among participants with life-limiting illness, delirium, and a delirium symptoms score (sum of Nursing Delirium Screening Scale behavioral, communication, and perceptual items) of 1 or more...
December 5, 2016: JAMA Internal Medicine
https://www.readbyqxmd.com/read/27918764/effect-of-fluorouracil-leucovorin-and-oxaliplatin-with-or-without-onartuzumab-in-her2-negative-met-positive-gastroesophageal-adenocarcinoma-the-metgastric-randomized-clinical-trial
#14
Manish A Shah, Yung-Jue Bang, Florian Lordick, Maria Alsina, Meng Chen, Stephen P Hack, Jean Marie Bruey, Dustin Smith, Ian McCaffery, David S Shames, See Phan, David Cunningham
Importance: Dysregulation of the mesenchymal-epithelial transition (MET) signaling pathway is associated with poor prognosis in gastroesophageal adenocarcinoma (GEC). We report results of METGastric, a phase 3 trial of the MET inhibitor onartuzumab plus standard first-line chemotherapy for human epidermal growth factor receptor 2 (HER2)-negative, MET-positive, advanced GEC. Objective: To determine whether the addition of onartuzumab to first-line fluorouracil, leucovorin, and oxaliplatin (mFOLFOX6) improves efficacy compared with mFOLFOX6 plus placebo in HER2-negative, MET-positive GEC...
December 1, 2016: JAMA Oncology
https://www.readbyqxmd.com/read/27918744/efficacy-of-naproxen-with-or-without-esomeprazole-for-pain-and-inflammation-in-patients-after-bilateral-third-molar-extractions-a-double-blinded-crossover-study
#15
G-M Weckwerth, L-F Simoneti, P Zupelari-Gonçalves, A-M Calvo, D-T Brozoski, T-J Dionísio, E-A Torres, J-R Lauris, F-A Faria, C-F Santos
BACKGROUND: Using a double-blinded randomized crossover design, this study aimed to evaluate acute postoperative pain management, swelling and trismus in 46 volunteers undergoing extractions of the two lower third molars, in similar positions, at two different appointments who consumed a tablet of either NE (naproxen 500 mg + esomepraz ole 20 mg) or only naproxen (500 mg) every 12 hours for 4 days. MATERIAL AND METHODS: Parameters were analyzed: self-reported pain intensity using a visual analog scale (VAS) pre- and postoperative mouth opening; incidence, type and severity of adverse reactions; total quantity consumed of rescue medication; and pre- and postoperative swelling...
December 6, 2016: Medicina Oral, Patología Oral y Cirugía Bucal
https://www.readbyqxmd.com/read/27918731/effects-of-passiflora-incarnata-and-midazolam-for-control-of-anxiety-in-patients-undergoing-dental-extraction
#16
L-P Dantas, A- de Oliveira-Ribeiro, L-M de Almeida-Souza, F-C Groppo
BACKGROUND: Anxiety symptoms are frequently observed in dental patients, whether they are undergoing simple or more invasive procedures such as surgery. This research aimed to compare the effects of Passiflora incarnata and midazolam for the control of anxiety in patients undergoing mandibular third molar extraction. MATERIAL AND METHODS: Forty volunteers underwent bilateral extraction of their mandibular third molars in a randomized, controlled, double-blind, crossover clinical trial...
December 6, 2016: Medicina Oral, Patología Oral y Cirugía Bucal
https://www.readbyqxmd.com/read/27918718/randomized-double-blind-placebo-controlled-multicenter-phase-ii-study-of-onartuzumab-plus-bevacizumab-versus-placebo-plus-bevacizumab-in-patients-with-recurrent-glioblastoma-efficacy-safety-and-hepatocyte-growth-factor-and-o-6-methylguanine-dna-methyltransferase
#17
Timothy Cloughesy, Gaetano Finocchiaro, Cristóbal Belda-Iniesta, Lawrence Recht, Alba A Brandes, Estela Pineda, Tom Mikkelsen, Olivier L Chinot, Carmen Balana, David R Macdonald, Manfred Westphal, Kirsten Hopkins, Michael Weller, Carlos Bais, Thomas Sandmann, Jean-Marie Bruey, Hartmut Koeppen, Bo Liu, Wendy Verret, See-Chun Phan, David S Shames
Purpose Bevacizumab regimens are approved for the treatment of recurrent glioblastoma in many countries. Aberrant mesenchymal-epithelial transition factor (MET) expression has been reported in glioblastoma and may contribute to bevacizumab resistance. The phase II study GO27819 investigated the monovalent MET inhibitor onartuzumab plus bevacizumab (Ona + Bev) versus placebo plus bevacizumab (Pla + Bev) in recurrent glioblastoma. Methods At first recurrence after chemoradiation, bevacizumab-naïve patients with glioblastoma were randomly assigned 1:1 to receive Ona (15 mg/kg, once every 3 weeks) + Bev (15 mg/kg, once every 3 weeks) or Pla + Bev until disease progression...
December 5, 2016: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/27918586/impact-of-preconception-micronutrient-supplementation-on-anemia-and-iron-status-during-pregnancy-and-postpartum-a-randomized-controlled-trial-in-rural-vietnam
#18
Phuong H Nguyen, Melissa Young, Ines Gonzalez-Casanova, Hoa Q Pham, Hieu Nguyen, Truong V Truong, Son V Nguyen, Kimberly B Harding, Gregory A Reinhart, Reynaldo Martorell, Usha Ramakrishnan
OBJECTIVE: Preconception micronutrient interventions may be a promising approach to reduce anemia and iron deficiency during pregnancy, but currently we have limited data to inform policies. We evaluated whether providing additional pre-pregnancy weekly iron-folic acid (IFA) or multiple micronutrient (MM) supplements compared to only folic acid (FA) improves iron status and anemia during pregnancy and early postpartum. METHODS: We conducted a double blind randomized controlled trial in which 5011 Vietnamese women were provided with weekly supplements containing either only 2800 μg FA (control group), IFA (60 mg Fe and 2800 μg FA) or MM (15 micronutrients with similar amounts of IFA)...
2016: PloS One
https://www.readbyqxmd.com/read/27918196/riboflavin-as-an-independent-and-accurate-biomarker-for-adherence-in-a-randomized-double-blind-and-placebo-controlled-clinical-trial
#19
V-M Sadagopa Ramanujam, Fatima Nayeem, Karl E Anderson, Yong-Fang Kuo, Nai-Wei Chen, Hyunsu Ju, Lee-Jane W Lu
BACKGROUND: Medication adherence is critical for success of clinical trials. OBJECTIVE: To assess oral riboflavin is an adherence marker. METHODS: Riboflavin was incorporated into active treatment and placebo pills for a clinical trial lasting for 2 years. RESULTS: The accuracy (area under the receiver operating curve) of urinary riboflavin was 0.91 as a binary classifier of adherence, and was similar or better than for two active study ingredients daidzein (0...
December 5, 2016: Biomarkers: Biochemical Indicators of Exposure, Response, and Susceptibility to Chemicals
https://www.readbyqxmd.com/read/27917845/conditions-of-endotracheal-intubation-with-and-without-muscle-relaxant-in-children
#20
Nermina Rizvanović, Senada Čaušević, Adisa Šabanović
Aim To compare intubation conditions and hemodynamic response of two induction regimens, with or without muscle relaxant using a combination of either fentanyl and propofol or propofol and suxamethonium. Methods A total of 80 children aged 4-12 years were enrolled in a prospective randomized double-blinded study. Children were randomly allocated in two equal groups. In group F induction was done with fentanyl and propofol, while propofol and suxamethonium were used in group S. Intubation conditions were assessed using Copenhagen Consensus Score (CCS), based on ease of laryngoscopy, position of vocal cords, degree of coughing, jaw relaxation and limb movements...
February 1, 2017: Medicinski Glasnik
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